Harrell Morgan, Fabbri Daniel, Levy Mia
All authors: Vanderbilt University, Nashville, TN.
JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.16.00044.
Adjuvant endocrine therapy is a long-term drug therapy prescribed to prevent recurrence of hormone receptor-positive breast cancer. Data on adjuvant endocrine therapy are reported though clinical trials, which may differ from treatment practice and outcomes in the general population of patients with breast cancer. With secondary use of electronic health record (EHR) data, we summarize adjuvant endocrine treatment practice and outcomes in real-world settings.
We analyzed treatment data derived from EHR data on 1,587 patients with stage I to III breast cancer at a National Cancer Institute-designated comprehensive cancer center to learn the frequencies of real-world adjuvant endocrine drug switches and discontinuation and to explore the potential cause for drug switches and discontinuation from medical records. We measured rates of drug use, drug switches, early drug discontinuation, adverse events, recurrence, and death. We also measured adverse events and change in menopause status as potential causes for drug switch and discontinuation.
Within the study population, approximately 49% of patients were lost to follow-up or did not complete adjuvant treatment through 5 years. Fifty-two percent of patients switched to a different endocrine therapy drug during their treatment. We found that age is correlated with drug switches and that adverse events are correlated with drug switches and discontinuation. We also found that patients who switched to an alternative endocrine therapy during treatment were more likely to complete 5 years of treatment.
This study describes long-term adjuvant endocrine treatment in real-world settings and demonstrates the ability to leverage longitudinal EHR data to characterize oral medication treatment patterns in patients with cancer.
辅助内分泌治疗是一种用于预防激素受体阳性乳腺癌复发的长期药物治疗。辅助内分泌治疗的数据通过临床试验报告,而这些数据可能与乳腺癌患者总体人群的治疗实践和结果有所不同。通过对电子健康记录(EHR)数据的二次利用,我们总结了现实环境中辅助内分泌治疗的实践和结果。
我们分析了来自一家美国国立癌症研究所指定的综合癌症中心的1587例I至III期乳腺癌患者的EHR数据中的治疗数据,以了解现实环境中辅助内分泌药物换药和停药的频率,并从病历中探索药物换药和停药的潜在原因。我们测量了药物使用、药物换药、早期药物停药、不良事件、复发和死亡的发生率。我们还测量了不良事件和绝经状态变化作为药物换药和停药的潜在原因。
在研究人群中,约49%的患者失访或在5年内未完成辅助治疗。52%的患者在治疗期间换用了不同的内分泌治疗药物。我们发现年龄与药物换药相关,不良事件与药物换药和停药相关。我们还发现,在治疗期间换用替代内分泌治疗的患者更有可能完成5年治疗。
本研究描述了现实环境中的长期辅助内分泌治疗,并证明了利用纵向EHR数据来描述癌症患者口服药物治疗模式的能力。